Enteral Nutrition (Food for Special Medical Purposes)NCT00503334
Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
A study testing preOP booster (oral nutritional supplement, food for special medical purposes) in people with Enteral Nutrition (Food for Special Medical Purposes), run by Fresenius Kabi at 1 site in Italy.
Trial summary
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Enteral Nutrition (Food for Special Medical Purposes)
- What is being tested?
- preOP booster (oral nutritional supplement, food for special medical purposes)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective pancreaticoduodenectomy
Who cannot join
- Concomitant chemotherapy
- Severe malnutrition (SGA score C)
- Conditions affecting gastric emptying
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.
- Being tested
- preOP booster (oral nutritional supplement, food for special medical purposes)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preOP booster (oral nutritional supplement, food for special medical purposes)Dietary supplement
3x1 dosage pre-operatively
| Study group | Role | What they receive |
|---|---|---|
| preOP booster | Experimental | Not described Receives: Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes) |
| preOP booster placebo | Placebo comparator | Not described Receives: Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
Measured: up to 30 days after surgery
Secondary outcomes (1)
postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Nutrition (Food for Special Medical Purposes)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marco Braga, Prof MD, Principal investigator, Università Salute-Vita San Raffaele, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503334
- Sponsor's protocol ID
- N-POB-03-IT
- Status last verified
- Nov 2008
- First submitted
- 16 Jul 2007
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery
- ClinicalTrials.gov ID
- NCT00503334
- Acronym / sponsor ID
- N-POB-03-IT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preOP booster | Experimental | Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes) |
| preOP booster placebo | Placebo comparator | Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective pancreaticoduodenectomy
Key exclusion criteria (3 listed)
- Concomitant chemotherapy
- Severe malnutrition (SGA score C)
- Conditions affecting gastric emptying
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preOP booster (oral nutritional supplement, food for special medical purposes)3x1 dosage pre-operatively | Dietary supplement | preOP booster, preOP booster placebo |
Primary outcome
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
Time frame: up to 30 days after surgery
1 secondary outcome
postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance
Time frame: up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Braga, Prof MD principal investigator
Università Salute-Vita San Raffaele, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preOP booster (oral nutritional supplement, food for special medical purposes) in people with Enteral Nutrition (Food for Special Medical Purposes), run by Fresenius Kabi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP; (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2008.